ISO 14971 Medical Device Risk Management

ISO 14971:2007 is an ISO standard for identifying hazards associated with medical devices, evaluating the related risks, controlling those risks, and monitoring the effectiveness of the controls.

This standard is a guide that helps identify and analyse risks related to medical devices. The annexes specified in the 2007 revision are listed below.

Treatment of negligible risks: when assessing Annexes 1 and 2 of Directive 93/42/EEC, the manufacturer must take all risks into account.

Acceptability of risks: reducing risks as far as possible, performing risk-benefit analysis.

Risk control options: for the ISO 14971 standard and risk management processes, you can consult Eurocert specialists.